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510(k) Data Aggregation
K Number
K191174Device Name
Mercy babyTAPE
Manufacturer
Children's Mercy Hospital
Date Cleared
2019-10-10
(162 days)
Product Code
PIR, FRW, FTY
Regulation Number
878.4800Why did this record match?
Product Code :
PIR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Mercy babyTAPE device is intended for use by health care professionals to estimate the body weight of infants between the ages of 0 days (birth) and 90 days, using circumferential measurements from specific anatomical landmarks made with the Mercy babyTAPE device for head and chest circumference.
Head: place the Mercy babyTAPE across the frontal bones, slightly above eyebrows and ears, over the occipital prominence, perpendicular to the long axis of the face.
Chest: place the Mercy babyTAPE around the upper torso, passing under the axilla and by the xyphoid process at the level of the nipple. Measure at end-exhalation.
Device Description
The Mercy babyTAPE device consists of a semi-durable or disposable flexible strip of paper, coated paper, fabric or plastic tape printed on both sides such that one side uses yellow color to indicate its use for the head circumference measurement, while the other side is printed with blue color to indicate its use for the chest circumference measurement. The start end of the device is indicated with color contrasting arrowheads that span the width of the device. Numbered bins are marked on each side proportional to the fractional body weight of newborn and infant patients. The markings correspond to a validated Mercy babyTAPE Method (calculation algorithm) for determining estimated infant body weight.
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K Number
K142469Device Name
2D Mercy TAPE & 3D Mercy TAPE
Manufacturer
Children's Mercy Hospital
Date Cleared
2015-05-01
(240 days)
Product Code
PIR
Regulation Number
878.4800Why did this record match?
Product Code :
PIR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Mercy TAPE device (2D and 3D models) is intended to estimate the body weight of pediatric patients between the ages of 2 months and 16 years, using linear measurements from specific anatomical landmarks made with the Mercy TAPE device for humeral length (HL, for the 2D model) or half-humeral length (HHL, for the 3D model) and the mid-upper arm circumference (MUAC).
The Mercy TAPE device may be less reliable for use in children with known or apparent limb deformities, or abnormal body proportions caused by conditions such as edema or severe malnutrition.
Device Description
The Mercy TAPE Device (2D and 3D Models) consists of semi-durable or disposable flexible strips of coated paper, fabric or plastic tape printed with numbered bins proportional to fractional body weight of pediatric patients. The markings correspond to the validated Mercy Method (calculation algorithm) for determining pediatric body weight using humeral length and mid-upper arm circumference.
The Mercy TAPE Device 2D Model consists of a single strip of tape that is used in two (2) stages to measure humeral length and mid-upper arm circumference. For the Mercy TAPE Device 3D Model, two (2) perpendicular strips of tape are designed to be joined into a sliding "T" shape so that humeral length and mid-upper arm circumference can be measured.
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